# FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - September 23, 2022

Source: https://www.globalkeysolutions.net/records/483/tentamus-india-private-limited/8217694f-c9f0-438f-a259-1feab2ad57a6

> FDA 483 for TENTAMUS INDIA PRIVATE LIMITED on September 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TENTAMUS INDIA PRIVATE LIMITED
- Inspection Date: 2022-09-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Megsan Labs Private Limited in Hyderabad, India, revealed three significant observations. The firm's quality control unit failed to follow written procedures, with issues such as non-working pressure gauges and inadequate controls for GMP data storage. Additionally, investigations into unexplained discrepancies lacked proper root-cause analysis and preventive actions, and laboratory control mechanisms showed deficiencies in contemporaneous documentation and record-keeping.

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## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/tentamus-india-private-limited/98546c5a-01a9-4157-9fc2-9254a69641af

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1